NuMED TYSHAK Instrucciones De Utilizacion página 3

P
RECAUTIONS
• Dilatation procedure should be conducted under fluoroscopic guidance with
appropriate x-ray equipment.
• Guidewires are delicate instruments. Care should be exercised while handling to help
prevent the possibility of breakage.
• Careful attention must be paid to the maintenance of tight catheter connections and
aspiration before proceeding to avoid air introduction into the system.
• Under no circumstances should any portion of the catheter system be advanced
against resistance. The cause of the resistance should be identified with fluoroscopy
and action taken to remedy the problem.
• If resistance is felt upon removal, then the balloon, guidewire, and the sheath should be
removed together as a unit, particularly if balloon rupture or leakage is known or
suspected. This may be accomplished by firmly grasping the balloon catheter and
sheath as a unit and withdrawing both together, using a gentle twisting motion
combined with traction.
• Before removing the catheter from the sheath it is very important that the balloon is
completely deflated.
• Proper functioning of the catheter depends upon its integrity. Care should be used
when handling the catheter. Damage may result from kinking, stretching, or forceful
wiping of the catheter.
I
NSTRUCTIONS FOR
Prior to valvuloplasty, carefully examine all equipment to be used during the procedure, including
the catheter, to verify proper function and that the catheter size is suitable for the specific proce-
dure for which it is intended. Also, inflate the dilatation catheter to the appropriate RBP and deflate
to verify proper function.
1.0 Remove balloon protector. Inspect the catheter for damage prior to insertion.
2.0 Check that all connections are tight. Fill and purge the dilatation balloon. Prime and flush
the distal lumen.
3.0 Prepare a peripheral vein site for catheter insertion. The femoral vein is a recommended site
for insertion.
4.0 Under fluoroscopic guidance advance the guidewire to the desired position. Pass the
catheter over the guidewire. An introducer should be utilized to facilitate catheter insertion.
5.0 Advance the catheter into the heart and through the valve under fluoroscopic guidance.
Place the catheter to position the mid-length of the balloon within the valve. A radiopaque
band[s] defines the center [or shoulders, if two] of the dilatation balloon.
6.0 The distal lumen is provided for guidewire tracking. An inflation device with pressure gauge
is required to monitor inflation pressure [refer to package label for RBP].
7.0 Perform dilatations using either a 50/50 or a 75/25 solution of saline and contrast medium,
respectively. Patient monitoring is required during dilatations. Balloon can be either partially
or fully inflated to achieve dilatation. DO NOT EXCEED THE RBP.
8.0 Deflate the balloon by drawing a vacuum with an inflation device with pressure gauge. Note:
The greater the vacuum applied and held during withdrawal, the lower the deflated balloon
profile. Gently withdraw the catheter. As the balloon exits the vessel, use a smooth, gentle,
steady motion. If resistance is felt upon removal, then the balloon, guidewire and the sheath
should be removed together as a unit under fluoroscopic guidance, particularly if balloon
rupture or leakage is known or suspected. This may be accomplished by firmly grasping the
balloon catheter and sheath as a unit and withdrawing both together, using a gentle twisting
motion combined with traction.
9.0 Apply pressure to the insertion site according to standard practice or hospital protocol for
percutaneous vascular procedures.
P C
OTENTIAL OMPLICATIONS
Potential balloon separation following balloon rupture or abuse and the subsequent need to use a
snare or other medical interventional techniques to retrieve the pieces.
U
SE
/A
DVERSE
E
FFECTS
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